[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4945 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 4945

To amend title XVIII of the Social Security Act to exclude ventilators 
from competitive acquisition programs under the Medicare program for 5 
                     years, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 31, 2019

Mr. Griffith (for himself, Mr. Welch, Mr. Bilirakis, Mr. Soto, and Mr. 
    Larson of Connecticut) introduced the following bill; which was 
 referred to the Committee on Energy and Commerce, and in addition to 
   the Committee on Ways and Means, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to exclude ventilators 
from competitive acquisition programs under the Medicare program for 5 
                     years, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Safeguarding Medicare Access to 
Respiratory Therapy Act of 2019''.

SEC. 2. EXCLUDING VENTILATORS AND CERTAIN OTHER RESPIRATORY ITEMS FROM 
              COMPETITIVE ACQUISITION PROGRAMS UNDER THE MEDICARE 
              PROGRAM FOR 5 YEARS.

    Section 1847(a)(2)(A) of the Social Security Act (42 U.S.C. 1395w-
3(a)(2)(A)) is amended by inserting ``excluding ventilators (whether 
invasive or noninvasive) and any other respiratory covered item (as 
defined in paragraph (13) of section 1834(a)) payable under paragraph 
(3) of such section and furnished on or after January 1, 2020, and 
before January 1, 2025,'' before ``and excluding drugs and 
biologicals.''.

SEC. 3. REQUIRING THE ESTABLISHMENT OF UPDATED NATIONAL COVERAGE 
              POLICIES TO REFLECT INNOVATION IN TECHNOLOGY FOR HOME 
              MECHANICAL VENTILATOR DEVICES UNDER THE MEDICARE PROGRAM.

    (a) In General.--Section 1869(f) of the Social Security Act (42 
U.S.C. 1395ff(f)) is amended by adding at the end the following new 
paragraph:
            ``(9) Technical expert panel review and update of national 
        coverage determinations for home mechanical ventilators and 
        certain other respiratory devices.--
                    ``(A) In general.--Not later than 90 days after the 
                date of the enactment of this paragraph, the Secretary 
                (through use of a contractor or otherwise) shall 
                establish a technical expert panel for purposes of 
                reviewing national coverage determinations with respect 
                to coverage under part B for home invasive and 
                noninvasive ventilators and other noninvasive 
                respiratory devices (including respiratory devices with 
                bi-level pressure capability) and making 
                recommendations for revising such determinations.
                    ``(B) Review, assessment, and recommendations.--Not 
                later than 1 year after the date the technical expert 
                panel described in subparagraph (A) is established (and 
                periodically thereafter as the Secretary determines 
                appropriate), the technical expert panel shall review 
                stakeholder input and clinical literature and make 
                recommendations to the Secretary, with respect to 
                national coverage determinations described in such 
                paragraph, relating to--
                            ``(i) defining home invasive ventilators 
                        and home noninvasive ventilators;
                            ``(ii) defining the term `respiratory 
                        failure' for purposes of establishing criteria 
                        for the appropriate use of home invasive or 
                        noninvasive ventilators;
                            ``(iii) establishing medical necessity 
                        criteria for the use of home invasive and 
                        noninvasive ventilators for individuals 
                        enrolled under part B diagnosed with 
                        respiratory failure and for such individuals 
                        not diagnosed with respiratory failure; and
                            ``(iv) any other aspects of home 
                        ventilators and similar devices that the 
                        technical expert panel determines are 
                        appropriate to ensure access to medically 
                        appropriate devices.
                    ``(C) Membership.--In establishing the technical 
                expert panel, the Secretary shall solicit 
                recommendations from interested stakeholders. The 
                technical expert panel shall be composed of a minimum 
                of 15 individuals with relevant expertise and 
                perspectives, including the following:
                            ``(i) Home invasive and noninvasive 
                        ventilator patients and caregivers.
                            ``(ii) Experts with relevant clinical 
                        experience and expertise, including researchers 
                        in respiratory care, pulmonologists, nurses, 
                        respiratory therapists, and other clinicians.
                            ``(iii) Experts with subject matter 
                        expertise in reimbursement systems and medical 
                        necessity requirements under this title.
                            ``(iv) Experts in the supply of devices and 
                        services for home ventilation therapy.
                            ``(v) Experts in the design, development, 
                        and manufacturing of home ventilation 
                        equipment.
                    ``(D) Use of the recommendations by the 
                secretary.--
                            ``(i) In general.--In consultation with 
                        stakeholders, the Secretary shall, based upon 
                        the recommendations described in subparagraph 
                        (B), update national coverage determinations 
                        for ventilators and devices described in 
                        paragraph (1).
                            ``(ii) Timing.--The Secretary shall 
                        finalize and implement updated national 
                        coverage determinations described in clause 
                        (i), taking into account public comments made 
                        during the determination process, not later 
                        than 9 months after any date on which the 
                        Secretary receives recommendations described in 
                        subparagraph (B) from the technical expert 
                        panel.
                    ``(E) Transparency.--The Secretary shall make the 
                minutes of all meetings of the technical expert panel 
                and all documentation relating to the formulation of 
                recommendations described in subparagraph (B) available 
                to the public through the Centers for Medicare & 
                Medicaid Services website.''.
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